| Location | Northridge, CA |
| Salary | $53.17–$55.17 Per Hour |
| Bill Rate | $80/hr USD |
| Job Description | " Engage as a quality core team member responsible for driving quality into the design and development of digital health solutions (medical mobile device applications (iOS/Android)/cloud technologies - AWS/IBM Watson)/data reports/AI/ML). " Drive the collaborative quality strategy for projects in alignment with business goals for cross-functional teams including R&D/Regulatory/Marketing/Operations. " Drive quality focused design and development of software within the software development lifecycle (Agile/waterfall/SAFe/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability. " Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements, design documents, code review, test results. verification and validation reports and defects. " Lead and conduct risk management activities including system risk analysis and software FMEA s. " Lead and drive CAPA (Corrective and Preventative Action) projects. " Participate in both internal and external regulatory audits and inspections. " Drive quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures (such as ISO13485/IEC62304/HIPAA/FDA/Security Standards/Data Privacy). " Responsibilities may also include the following and other duties may be assigned. " Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures. " Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation. " Defines appropriate measures to ensure product quality. " Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. " Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. " Reviews software systems design, change specifications, and plans against contractual and/or process requirements. " Reviews include applicable specifications, materials, tools, techniques, and methodologies. " Provides or directs verification and validation of software system requirements, traceability, and testability. Minimum Qualifications: " Bachelor s degree in engineering, Science or Technical Field with 4+ years of experience in Engineering, Software Development and/or Quality OR Advanced " Degree Engineering, Science or Technical Field with 2+ years of experience in Engineering, Software Development and/or Quality Nice to Have: " Experience in software design and development, verification, validation and testing activities. [embedded software and/or mobile application development [(Java (objective-C), and Kotlin (Swift)) and/or cloud infrastructure services (such as Amazon AWS/Microsoft Azure/IBM Watson). " Experience executing in the SDLC environment leveraging ALM tools (Eg: PTC Integrity/Atlassian Suite/TFS), defect tracking tools (Eg:Jira), development tools (Git, SourceTree, Android Studio, GitLab), test tools (Selenium/JUnit), CI/CD tools (Jenkins). " Exposure to medical device compliance standards (such as ISO13485/IEC62304/HIPAA/FDA/Security Standards/Data Privacy). " Ability to author technical reports, business correspondence and standard operating procedures. " Exposure in data driven insight solutions leveraging machine learning/artificial intelligence (AI). " Exposure with wireless communication protocols (Eg: Bluetooth). " Exposure to n-tier architecture models and/or experience with ITIL processes/IT systems. " Working knowledge of integrated digital health systems including consumer products such as Apple Inc./Android products. " Certified scrum master or SAFe or Black Belt or Green Belt or CQE |